Glytone Clarifying Gel

Generic Name: hydroquinone
Dosage Form: gel

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Glytone Skin bleaching Clarifying



Dosage Apply Clarifying Gel nightly to the affected area or as directed by your physician.



Warnings Contains Sodium Bisulfite, a sulfite that may cause serious allergic type reactions (eg hives, itching, wheezing, anaphlyaxis, severe asthma attack) in certain susceptible persons.



Contains Each gram of Clarifying Gel contains 40 mg of Hydroquinone USP in a gel base of Purified Water, Propylene Glycol, Carbomer 940, Sodium Bisulfite, Edetate Disodium, Sorbic Acid, Glycerin.



Distributed by Genesis Pharmaceutical Inc

Parsippany, NJ 07054

Made in USA

18004598663


NDC 64760 202 01

Glytone skin bleaching clarifying gel

rx only

hydroquinone usp 4%

Net wt. 2oz. (56 g)

GLYTONE CLARIFYING  
hydroquinone gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64760-202
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
CARBOMER HOMOPOLYMER TYPE C  
SODIUM BISULFITE  
EDETATE DISODIUM  
SORBIC ACID  
GLYCERIN  
Packaging
# Item Code Package Description
1 NDC:64760-202-01 1 TUBE (TUBE) in 1 BOX
1 56 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 11/09/2010
Labeler - Glytone (117196928)
Establishment
Name Address ID/FEI Operations
Genesis Pharmaceutical 117196928 manufacture
Revised: 03/2010
 
Glytone



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